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  • Title: Short- and long-term safety assessment of a two-compound ointment containing calcipotriene/betamethasone dipropionate (Taclonex/Daivobet/Dovobet ointment): hypothalamic-pituitary-adrenal axis function in patients with psoriasis vulgaris.
    Author: Fleming C, Ganslandt C, Leese GP.
    Journal: J Drugs Dermatol; 2010 Aug; 9(8):969-74. PubMed ID: 20684147.
    Abstract:
    The two-compound ointment (Taclonex/Daivobet/Dovobet ointment) combining calcipotriene 50 microg/g and betamethasone 0.5 mg/g (as dipropionate) is very effective in the treatment of psoriasis vulgaris. There is a possibility that hypothalamo-pituitary-axis (HPA) suppression may occur if the potent corticosteroid component is absorbed to a sufficient extent. The effect of the two-compound ointment on HPA axis function was assessed in two studies. Study 1 was a four-week, double-blind study which compared the effects of the two-compound ointment with betamethasone 0.5 mg/g (as dipropionate; Diprosone) ointment in 24 patients with extensive psoriasis (involving 15-30% of the body surface area). No patients receiving the two-compound ointment had HPA axis suppression. Study 2 assessed HPA axis function after four and 52 weeks in a subset of patients (n = 19) participating in a long-term safety study. Patients were treated with the two-compound ointment for the first four weeks followed by 48 weeks of treatment as needed with either 1) two-compound ointment; 2) two-compound ointment alternating with calcipotriene four-weekly or 3) calcipotriene. No patients using the two-compound ointment for all 52 weeks or alternating four-weekly with calcipotriene had HPA axis suppression.
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